Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Coronary Artery Disease Clinical Trial

— REPAIR  

Official title:

Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269461
• Other study ID #: REPAIR
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2020
• Source: Scitech Produtos Medicos Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Description:

The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.

All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2020
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =18 and = 80years;

• Symptomatic CAD or documented myocardial ischemic disease;

• Up to 2 de novo lesions on native coronary arteries;

• Lesion length = 29mm;

• Reference vessel diameter between =2.5 and = 3.5 mm;

• Stenose at target lesion = 70% and = 99%.

Exclusion Criteria:

• STEMI within the last 72 hours pre-procedure;

• renal insufficiency;

• Left Main stenosis > 50%;

• Ostial lesions;

• Bifurcation lesions with side branch =2mm;

• More than one lesion > 50% at the target vessel;

• Left Ejection Fraction less than 30%;

• Previous (less than 6 months) PCI at the target vessel.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Angiography and Optical Coherence Tomography evaluations
coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations

Locations

Country	Name	City	State
Brazil	Hospital do Coração Anis Rassi	Goiânia	Goiás
Brazil	Paraná Medical Research Center	Maringá	Paraná
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo	SP
Brazil	Hospital Evangélico do Espírito Santo	Vila Velha	Espírito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Scitech Produtos Medicos Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Coverage	Change in the tissue coverage percentage measured by OCT	3 months
Secondary	in-stent late lumen loss	in-stent late lumen loss	3 months
Secondary	Stent Thrombosis	Stent Thrombosis Rates	2 years
Secondary	Target Vessel Failure	Target Vessel Failure (Death, MI and new revascularization)	2 years